Health Trials

A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder

ConditionIrritability Associated With Autism Spectrum Disorder
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-17
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.

Participants must have an ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).

Disqualifiers

Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).

Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.

Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.

Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.

Trial design

Design model

Parallel

Treatments tested in this trial

  • KarXT

    Drug

    Specified dose on specified days

  • KarX-EC

    Drug

    Specified dose on specified days

  • KarXT + KarX-EC Matching Placebo

    Drug

    Specified dose on specified days

Treatment groups

176 Participants
are divided into 2 treatment groups
Group A: KarXT + KarX-EC ArmExperimental treatment 2 interventions
Group B: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8

Time frame
Week 8

Secondary outcomes

1

Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8

Time frame
Week 8
2

Number of Participants With ABC-I response at Week 8

ABC-I response is determined by ≥ 25% reduction in ABC-I score from baseline.

Time frame
Week 8
3

Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8

Time frame
Week 8
4

Change From Baseline on the Stereotypic Behavior Subscale at Week 8

Time frame
Week 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: